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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / November 2025 / K251293

510(k) cleared

CardioVision

Icardio.Ai · Nov 21, 2025 · K251293

FDA cleared the CardioVision from Icardio.Ai on Nov 21, 2025 under K251293, a traditional 510(k). The device falls under product code QUO, Adjunctive Heart Failure Status Indicator, regulated at 21 CFR 870.2200 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 25, 2025. The decision came 210 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Icardio.Ai in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251293?

K251293 is the FDA 510(k) for CardioVision, submitted by Icardio.Ai. FDA's decision date was Nov 21, 2025, under product code QUO (Adjunctive Heart Failure Status Indicator).

Who makes the CardioVision?

Icardio.Ai, based in West Hollywood, CA, is the applicant of record for K251293.

How long did the K251293 review take?

FDA received the submission on Apr 25, 2025 and issued its decision on Nov 21, 2025, 210 days later.

← All decisions in November 2025